With more than 50% of all clinical trials being conducted overseas, investigator’s brochure translations (IB translations) are an essential multilingual communications asset and are necessary for regulatory compliance. While trial sponsors are responsible for high volumes of documentation throughout all clinical trial phases, the investigator’s brochure is one of the most important documents and functions primarily to assess the benefits and risks of the investigational product (IP) being studied. The investigator’s brochure also details information like the chemical, physical, pharmaceutical properties, and formulas of the IP, as well as any side effects and the safety measures outlined in the study protocol. For both clinical and non-clinical studies, the investigator’s brochure must be presented to investigators, often in the languages of the country where the trial is being conducted. To help sponsors and other stakeholders throughout the clinical trials process, CSOFT Health Sciences offers investigator’s brochure translations with fast turnaround times in 250+ languages.
End-to-End Clinical Trial Translations
As more and more clinical trials incorporate innovative technology and focus on patient-centric care, the need for multilingual trial documents is essential for communications and international regulatory compliance. Whether you are a pharmaceutical company or medical device manufacturer, bringing new products to market necessitates translations for a broad range of clinical trial documents, in addition to ensuring the highest degree of accuracy by using localization solutions like linguistic validation. To help trial stakeholders meet international regulations for clinical trials, CSOFT Heath Sciences offers a full range of clinical trial translations, including:
Learn more about our full coverage of clinical trial translations.
Drug Development Process Documentation Translations
With a growing number of drugs being developed in the pharmaceutical industry, drug development process documentation translations are necessary to adhere to regulatory standards to access markets across the globe. Whether for a pharmaceutical company, clinical research organization, the U.S Food and Drug Administration (FDA), or the European Union (EU), process documentation ensures that drugs going through all phases of the development cycle meet regulations as needed to ensure safety and efficacy.
With a global team of 10,000+ in-country linguists and subject matter experts, CSOFT Health Sciences provides high-quality customized medical translation and localization solutions for a full range of content, documents, and materials for research organizations and companies in the drug development field.
Learn more about our drug development process documentation translations.
Adverse Event Reporting Translations
To avoid under-reporting adverse events and meet time-sensitive deadlines for clinical reporting in clinical trials, adverse event reporting translations are essential for regulatory compliance and successfully bringing new products to market. During clinical trials, adverse events (AE), serious adverse events (SAE), and adverse drug reactions (ADRs) are expected to be reported to the regulating agency within specific timelines, which can be as short as 7 days as outlined under FDA regulations for Investigational New Devices (INDs). With an increasing number of clinical trials being conducted internationally, providing multilingual adverse event reports and documents is required by many global regulators and is essential for avoiding potentially life-threatening situations. With a global network of linguists and a team of subject matter experts when it comes to pharmacovigilance processes, CSOFT Health Sciences offers fast turnaround times to meet your adverse event reporting translation needs across 250+ languages.
Learn more about our adverse event reporting translations.
Investigational Medicinal Product Dossier (IMPD) Translations
The investigational medicinal product dossier (IMPD), also known as an IMP dossier, is a crucial document for clinical trial applications, making IMPD translations essential for access to the European clinical trial market. When testing a non-authorized investigational medicinal product (IMP), an IMPD is necessary to detail the quality of the IMP, as well as the pre-clinical, clinical, and risk and benefit analysis outlined in an Investigator’s Brochure (IB). Even for an authorized IMP, an IMPD may be necessary in addition to a Summary of Product Characteristics (SmPC) to approve the placebo used in a clinical trial for use. Accurate and efficient translation of both full and simplified investigational medicinal product dossiers (sIMPD) across languages is essential for regulatory compliance and access to European clinical trials. CSOFT Health Sciences’ global team of over 10,000 subject matter expert linguists is well-versed in navigating translation of these complex regulatory documents, all with quick turnaround times.
Learn more about our IMPD translations.
Quality Assurance
CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time. Every step of the way, CSOFT has you covered.
Learn more about our quality assurance process.
Data Security
With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.